Reported Feb 1, 2017 · Terminated
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories…
Actavis Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Actavis Inc · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
- Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
- Lot codes and dates
Lot #: GA51265Ex[p. Jan-2017GA51454GA51553GA51583Exp. Feb-2017GA51598GA51724GA51725GA51749Exp. Mar-2017
- Amount recalled
- 164,844 units
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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